Clinical Trial Comparing Gemcitabine and Vandetanib Therapy With Gemcitabine Alone in Pancreatic Carcinoma (ViP)

This study is currently recruiting participants.
Verified May 2012 by University of Liverpool
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Dr Gary MIddleton, University of Liverpool
ClinicalTrials.gov Identifier:
NCT01601808
First received: February 22, 2012
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

ViP is a double blinded clinical trial which will compare gemcitabine and vandetanib chemotherapy with gemcitabine alone in patients with locally advanced or metastatic pancreatic carcinoma.


Condition Intervention Phase
Pancreatic Cancer
Drug: Placebo
Drug: Caprelsa (vandetanib)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Phase II, Double Blinded, Multicentre, Randomised Clinical Trial Comparing Combination Gemcitabine and Vandetanib Therapy With Gemcitabine Therapy Alone in Locally Advanced or Metastatic Pancreatic Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Liverpool:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation ] [ Designated as safety issue: No ]
    To assess whether survival times for patients receiving gemcitabine plus vandetanib are longer than for those patients receiving gemcitabine alone as first line treatment for advanced pancreatic cancer


Secondary Outcome Measures:
  • Progression-free survival time [ Time Frame: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation ] [ Designated as safety issue: No ]
  • Number and types of adverse events [ Time Frame: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation ] [ Designated as safety issue: Yes ]
  • Patient pain assessment [ Time Frame: Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Gemcitabine and Placebo
Standard therapeutic arm. Placebo orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles.
Drug: Placebo
Orally once a day, continuously throughout the study
Experimental: Gemcitabine and vandetanib
Experimental arm. Vandetanib orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles.
Drug: Caprelsa (vandetanib)
Orally once a daily, continuously throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically or cytologically proven pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas.
  • Locally advanced or metastatic disease precluding curative surgical resection or definitive locally directed therapies such as chemo radiation. Patients who have relapsed following previously resected Pancreatic Cancer can be included.
  • Contrast enhanced computerised tomography (CT) scan of the thorax, abdomen and pelvis within 28 days prior to commencing treatment.
  • Unidimensionally measurable disease as shown by CT scan, in accordance with RECIST guidelines (version 1.1)
  • ECOG performance status 0, 1 or 2 where the investigator feels that treatment with combination chemotherapy.
  • Platelets ≥100 x 109/l; WBC ≥ 3 x 109/l; neutrophils ≥ 1.5 x 109/l at entry.
  • Documented Life expectancy > 3 months.
  • Informed written consent

Exclusion Criteria:

  • Laboratory results:

    • Serum bilirubin ≥ 1.5x the upper limit of reference range (ULRR).
    • Haemoglobin < 10G/dl
    • Creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula)**. Patients with a creatinine clearance of ≥30mL/minute and <50mL/minute should begin vandetanib on a reduced dose of 200mg.
    • Potassium, ≤4.0 mmol/L despite supplementation; or > 5.5 mmol/L
    • Magnesium below the normal range despite supplementation, or > 1.23 mmol/L
    • Serum calcium is > 2.9 mmol/L. In cases where serum calcium is below the normal range this can be substituted with the value for calcium adjusted for albumin, if this is below the normal range despite supplementation patients should be excluded.
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or alkaline phosphatase (ALP) >2.5 x ULRR or > 5x ULRR if judged by the investigator to be related to liver metastases.
  • Medical or psychiatric conditions compromising informed consent.
  • Intracerebral metastases or meningeal carcinomatosis.
  • Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
  • Evidence of severe or uncontrolled systemic disease or any concurrent condition
  • Clinically significant cardiovascular eventclassification of heart disease ≥2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
  • History of arrhythmia which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded.
  • QTc prolongation with other medications that required discontinuation of that medication.
  • Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
  • Presence of left bundle branch block (LBBB).
  • QTc with Bazett's correction that is un-measurable or ≥ 480 msec on screening ECG. Patients who are receiving a drug that has a risk of inducing Torsades-de-Pointes are excluded if QTc is ≥ 460 msec.
  • Any concurrent medication with a known risk of inducing Torsades-de-Pointes, that in the investigator's opinion cannot be discontinued, are allowed.
  • Concomitant medications that are potent inducers.
  • Hypertension not controlled by medical therapy.
  • Currently active diarrhoea.
  • Malabsorption syndrome.
  • Pregnancy or breast feeding.
  • Previous chemotherapy for locally advanced and metastatic disease. Adjuvant chemotherapy for resected pancreatic cancer will be permitted provided that chemotherapy was completed > 12 months previously.
  • Radiotherapy within the last 4 weeks prior to start of study treatment.
  • Concurrent malignancies or invasive cancers diagnosed within past 5 years.
  • Chemotherapy directed at tumour apart from that described in this protocol.
  • All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601808

Contacts
Contact: Zaira Yunus 0151 7948935 zyunus@liv.ac.uk

Locations
United Kingdom
Belfast City Hospital Not yet recruiting
Belfast, United Kingdom, BT9 7AB
Principal Investigator: Dr Martin Eatock         
The Royal Bournemouth Hospital Recruiting
Bournemouth, United Kingdom, BH7 7DW
Principal Investigator: Dr Tamas Hickish         
Bristol Haematology and Oncology Centre Not yet recruiting
Bristol, United Kingdom, BS2 8ED
Principal Investigator: Dr Stephen Falk         
Royal Surrey County Hospital Recruiting
Guildford, United Kingdom, GU2 7XX
Principal Investigator: Dr Gary Middleton         
Clatterbridge Centre for Oncology Recruiting
Liverpool, United Kingdom, CH63 4JY
Principal Investigator: Professor Daniel Palmer         
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom, L69 3GA
Principal Investigator: Professor Daniel Palmer         
Guys & St Thomas Hospital Recruiting
London, United Kingdom, SE1 9RT
Principal Investigator: Dr Paul Ross         
Royal Marsden Hospital Not yet recruiting
London, United Kingdom, SW3 6JJ
Principal Investigator: Professor David Cunningham         
St Bartholomew's Hospital Not yet recruiting
London, United Kingdom, EC1A 7BE
Principal Investigator: Dr David Propper         
The Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Principal Investigator: Dr Richard Hubner         
James Cook University Hospital Recruiting
Middlesbrough, United Kingdom, TS4 3BW
Principal Investigator: Dr Nick Wadd         
Freeman Hospital Not yet recruiting
Newcastle, United Kingdom, NE7 7DN
Principal Investigator: Dr Fareeda Coxon         
Nottingham City Hospital Recruiting
Nottingham, United Kingdom, NG5 1PB
Principal Investigator: Dr Srinivasan Madhusudan         
Weston Park Hospital Recruiting
Sheffield, United Kingdom, S10 2SJ
Principal Investigator: Dr Jonathan Wadsley         
Sponsors and Collaborators
University of Liverpool
AstraZeneca
Investigators
Principal Investigator: Dr Gary Middleton Royal Surrey County Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr Gary MIddleton, Consultant Medical Oncologist, University of Liverpool
ClinicalTrials.gov Identifier: NCT01601808     History of Changes
Other Study ID Numbers: 2010-021951-26, 74555382
Study First Received: February 22, 2012
Last Updated: May 16, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Carcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 15, 2014